A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR)
Public ClinicalTrials.gov record NCT04477707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Observational Study of Routine Ophthalmological Examinations of Patients Included in the 2 Bayer Sponsored Phase 3 Clinical Trials FIDELIO and FIGARO to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.
Study identification
- NCT ID
- NCT04477707
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 206 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 23, 2020 (Actual)
- Primary completion
- Jun 25, 2021 (Actual)
- Completion
- Jun 25, 2021 (Actual)
- Last update posted
- Jun 29, 2022
2020 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Institute of Renal Research - Chula Vista | Chula Vista | California | 91910 | — |
| California Institute of Renal Research, Inc. - El Centro | El Centro | California | 92243 | — |
| Elixia at Florida Kidney Physicians Southeast | Fort Lauderdale | Florida | 33308 | — |
| John H Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | — |
| Crescent City Clinical Research Center, LLC | Metairie | Louisiana | 70006 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Office of Osvaldo A. Brusco, MD | Corpus Christi | Texas | 78414 | — |
| MedResearch, Inc. | El Paso | Texas | 79902-4672 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212-4740 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04477707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2022 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04477707 live on ClinicalTrials.gov.